US20040002698A1 - Thermal ablation with deployable cage - Google Patents
Thermal ablation with deployable cage Download PDFInfo
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- US20040002698A1 US20040002698A1 US10/183,600 US18360002A US2004002698A1 US 20040002698 A1 US20040002698 A1 US 20040002698A1 US 18360002 A US18360002 A US 18360002A US 2004002698 A1 US2004002698 A1 US 2004002698A1
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- thermal ablation
- fluid
- ablation catheter
- medical device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
- A61B2017/4216—Operations on uterus, e.g. endometrium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
Definitions
- the present invention relates to a medical device and to a method for thermal ablation, and more specifically to a thermal ablation catheter, having a deployable cage suitable for use in a uterus, for ablation of endometrial cells and tissue within the uterus.
- a thermal ablation catheter having a deployable cage suitable for use in a uterus, for ablation of endometrial cells and tissue within the uterus.
- the term “medical device” includes a medical or surgical device.
- menorrhagia Millions of women suffer from excessive menstrual bleeding (menorrhagia).
- a commonly used therapy to treat menorrhagia involves inserting a balloon catheter or a distensible bladder into the uterus, filling the balloon with a thermally conductive fluid, and then heating the fluid to thermally ablate the endometrial lining of the uterus.
- thermal balloon therapy is effective for treating menorrhagia in women who have a smooth uterine lining, such balloon therapy is not recommended for women who have uterine conditions such as myomas, polyps, or irregular uterine shapes, etc.
- a medical device for use in thermal ablation therapy.
- the medical device includes a thermal ablation catheter and a deployable cage assembly having a plurality of arms.
- Each of the arms includes a pair of opposed ends attached to the thermal ablation catheter.
- each of the arms is movable between a relaxed configuration and a deployed configuration. More particularly, in its relaxed configuration, each of the arms is substantially proximate to the thermal ablation catheter, while in its deployed configuration, it cooperates with the other arms to form an open structure which extends radially outward from the thermal ablation catheter.
- the thermal ablation catheter includes a fluid stem and a plurality of fluid ports in communication with the fluid stem.
- the fluid ports are surrounded by the open structure.
- the thermal ablation catheter includes a distensible bladder that serves as an endocervical seal.
- the distensible bladder is sized and shaped to be inflatable from a collapsed configuration to an expanded configuration.
- a method is also disclosed for performing thermal ablation therapy using the medical device. Initially, the distal end of the thermal ablation catheter is inserted into a uterus. The cage assembly is deployed such that it forms an open structure which extends radially outward from the thermal ablation catheter. Then, a fluid is supplied to the uterus through the distal end of the thermal ablation catheter. Lastly, the fluid is conductively heated to a desired temperature which is maintained for a desired time period.
- FIG. 1 is a front perspective view of a medical device constructed in accordance with the present invention
- FIG. 2 is a front view of a thermal ablation catheter of the medical device shown in FIG. 1, which shows a deployable cage assembly in a relaxed configuration and a distensible bladder in a collapsed configuration;
- FIG. 3 is a cross-sectional view of the thermal ablation catheter shown in FIG. 2, taken along section lines III-III and looking in the direction of the arrows, illustrated without the distensible bladder;
- FIG. 4 is an enlarged view of the view shown in FIG. 3;
- FIG. 5 is an exploded, perspective view of the thermal ablation catheter shown in FIG. 2, illustrated without the distensible bladder;
- FIG. 6 is a perspective view of the thermal ablation catheter shown in FIG. 2, which shows the deployable cage assembly in a deployed configuration and the distensible bladder in an expanded configuration;
- FIG. 7 is a perspective view of a heating assembly
- FIG. 8 is a front view of the heating assembly shown in FIG. 7;
- FIG. 9 is a top perspective view of a cap
- FIG. 10 is a bottom perspective view of the cap shown in FIG. 9;
- FIG. 11 is a cross-sectional view of the cap shown in FIG. 10, taken along section lines XI-XI and looking in the direction of the arrows;
- FIG. 12 is a partial, cross-sectional view of a handgrip portion shown in FIG. 1;
- FIG. 13 is a schematic view of a female uterus and the thermal ablation catheter shown in FIG. 2, which shows a distal portion of the thermal ablation catheter in contact with the uterine cavity;
- FIG. 14 is a view similar to the view shown in FIG. 13, except that the deployable cage assembly is in a deployed configuration and the distensible bladder is in an expanded configuration.
- FIG. 1 shows a medical device 10 having a handgrip portion 12 and a thermal ablation catheter 14 removably connected thereto.
- Various cables are provided for connecting the medical device 10 to external sources.
- a fluid line 16 is provided for connecting the medical device 10 to a fluid source (not shown).
- a cable 18 is provided for connecting the medical device 10 to a controller (not shown).
- a pressure cable 20 is provided for monitoring pressure throughout the procedure.
- an impeller cable 22 is also provided for reasons discussed hereinafter.
- the thermal ablation catheter 14 includes an outer sheath or tubular member 24 and a distensible bladder 26 attached thereto.
- the distensible bladder 26 is sized and shaped to inflate into a fully expanded configuration as shown in FIG. 6 and to deflate into a fully collapsed configuration as shown in FIG. 2.
- a passageway (not shown) is provided for receiving air and vacuum and is connected to an exterior line 28 .
- the passageway is connected to a perforation in the form of a vent 29 , which is formed on the tubular member 24 , located underneath the distensible bladder 26 .
- the air supplied via the passageway can be used to inflate the distensible bladder 26 to its fully expanded configuration as shown in FIG. 6, and the vacuum supplied via the passageway can be used to deflate the distensible bladder 26 to its fully collapsed configuration as shown in FIG. 2.
- the tubular member 24 includes a proximal end 30 which is sized and shaped to be insertable into the handgrip portion 12 (see FIG. 1) and a distal end 32 which is sized and shaped to be insertable into the uterus for reasons discussed hereinafter.
- the tubular member 24 is made from a material, such as stainless steel, teflon, or silicone, which can have a range of stiffness from rigid to flexible.
- the tubular member 24 has a length of approximately 230 mm and a diameter in a range from about 3 mm to about 10 mm. It will be understood that the above dimensions for the tubular member 24 are merely exemplary and that the tubular member 24 can have other dimensions.
- the distensible bladder 26 is made from a material, such as latex, silicone, or other elastomeric material, and when inflated, conforms to the shape of the cervical canal so as to seal the cervical canal, as will be discussed in greater detail hereinafter.
- the thermal ablation catheter 14 further includes a fluid stem 34 sized and shaped to be coaxially received within the tubular member 24 .
- the fluid stem 34 includes a proximal end 36 and a distal end 38 .
- a passageway (not shown) is provided for receiving a fluid (e.g., water, saline solution, high viscous gelatins, glycerol, propylene glycol, etc.).
- a fluid e.g., water, saline solution, high viscous gelatins, glycerol, propylene glycol, etc.
- the passageway extends between the proximal end 36 and the distal end 38 and is connected to the fluid line 16 (see FIG. 1).
- the fluid stem 34 has four longitudinal grooves on its outer surface so as to form four longitudinally extending bars 42 a - d .
- a longitudinal groove 44 a is formed between an adjacent pair of bars 42 a - b
- a longitudinal groove 44 b is formed between an adjacent pair of bars 42 b - c
- a longitudinal groove 44 c is formed between an adjacent pair of bars 42 c - d
- a longitudinal groove 44 d is formed between an adjacent pair of bars 42 d - a.
- the fluid stem 34 is made from a material, such as stainless steel, Teflon, nitinol, etc. As illustrated in FIG. 5, the fluid stem 34 has a diameter that is smaller than that of the tubular member 24 .
- a heating assembly 46 is provided and is sized and shaped to be coaxially received within the fluid stem 34 . More particularly, the heating assembly 46 has a heater core 52 which extends from the tubular member 24 , when assembled as shown in FIG. 2, and an extension 50 which is sized and shaped to be coaxially received within the distal end 38 of the fluid stem 34 . Referring to FIGS. 7 and 8, the heating assembly 46 includes a heater filament or wire 54 wrapped around the heater core 52 . Heater wire leads (not shown) extend between the cable 18 (see FIG. 1) and the heating wire 54 .
- a plurality of fluid outlet ports 56 is circumferentially positioned adjacent a distal end 57 of the heating assembly 46
- a plurality of fluid inlet ports 58 is circumferentially positioned adjacent a proximal end 59 of the heating assembly 46 .
- the fluid outlet ports 56 and the fluid inlet ports 58 are in communication with the passageway of the fluid stem 34 (see FIG. 5).
- Thermocouples 61 can be employed within the heating assembly 46 to provide monitoring and control of the temperature within the uterine cavity 118 .
- FIG. 5 illustrates a deployable cage assembly 60 which cooperates with the fluid stem 34 and is coaxially received over the heating assembly 46 .
- the deployable cage assembly 60 is sized and shaped to move between a deployed configuration as shown in FIG. 6, and a relaxed configuration as shown in FIG. 2.
- the deployable cage assembly 60 has a distal portion 62 which is coaxially received over the heating assembly 46 and a proximal portion 64 which cooperates with the fluid stem 34 .
- the deployable cage assembly 60 includes four longitudinally extending arms 66 a - d , each of which is movable from a relaxed configuration (see FIG. 2), in which the extending arms 66 a - d are proximate to the thermal ablation catheter 14 and have an unbowed shape, to a deployed configuration (see FIG. 6), in which the extending arms 66 a - d have a bowed shape and cooperate with each other to form an arcuate-shaped open structure 63 (see FIG. 6), which extends radially outward from the thermal ablation catheter 14 .
- the open structure 63 is located on the distal portion 62 of the deployable cage assembly 60 and is exposed (i.e., not covered by the tubular member 24 ). More particularly, the extending arm 66 a is sized and shaped to be received within the longitudinal groove 44 a formed between the bars 42 a - b of the fluid stem 34 , while the extending arm 66 b is sized and shaped to be received within the longitudinal groove 44 b formed between the bars 42 b - c of the fluid stem 34 .
- the extending arm 66 c is sized and shaped to be received within the longitudinal groove 44 c formed between the bars 42 c - d
- the extending arm 66 d is sized and shaped to be received within the longitudinal groove 44 d formed between the bars 42 d - a .
- the extending arm 66 a has a fixed end 68 a at the distal portion 62 and a tab 69 a at a free end and at the proximal portion 64 extending perpendicularly to the extending arm 66 a
- the extending arm 66 b has a fixed end 68 b at the distal portion 62 and a tab 69 b at a free end and at the proximal portion 64 extending perpendicularly to the extending arm 66 b .
- the extending arm 66 c has a fixed end 68 c at the distal portion 62 and a tab 69 c at a free end and at the proximal portion 64 extending perpendicularly to the extending arm 66 c
- the extending arm 66 d has a fixed end (not shown) at the distal portion 62 and a tab (not shown) at a free end and at the proximal portion 64 extending perpendicularly to the extending arm 66 d.
- a cap 70 is connected to the extending arms 66 a - d at the distal portion 62 of the deployable cage assembly 60 and is coaxially received over the distal end 57 of the heating assembly 46 (see FIG. 7).
- the cap 70 includes a cylindrical portion 72 and a connecting element 74 attached thereto.
- the connecting element 74 includes a center portion 75 defined by a lumen 76 sized and shaped to coaxially receive the distal end 57 of the heating assembly 46 (see FIG. 7), and also includes four projections 78 a - d extending from the center portion 75 .
- An opening 80 a is formed between an adjacent pair of projections 78 a - b and is sized and shaped to receive the end 68 a of the extending arm 66 a (see FIG. 5), while an opening 80 b is formed between an adjacent pair of projections 78 b - c and is sized and shaped to receive the end 68 b of the extending arm 66 b (see FIG. 5). Also, an opening 80 c is formed between an adjacent pair of projections 78 c - d and is sized and shaped to receive the end 68 c of the extending arm 66 c (see FIG. 5), while an opening 80 d is formed between an adjacent pair of projections 78 d - a and is sized and shaped to receive the end of the extending arm 66 d (see FIG. 5).
- the deployable cage assembly 60 also includes a mating element 80 located at the proximal portion 64 and sized and shaped to be received within the handgrip portion 12 (see FIG. 1).
- the mating element 80 is movable between a retracted position, in which the tabs 69 a - c of the extending arms 66 a - d are spaced a first distance from the fix ends 68 a - c thereof, and an extended position, in which the tabs 69 a - c are spaced a second distance from the fixed ends 68 a - c , the second distance being less than the first distance.
- the mating element 80 has a plurality of circumferentially spaced slots. More particularly, a slot 82 a is sized and shaped to mate with the tab 68 a of the extending arm 66 a , while a slot 82 b is sized and shaped to mate with the tab 68 b of the extending arm 66 b . Also, a slot (not shown) is sized and shaped to mate with the tab 68 c of the extending arm 66 c , while a slot (not shown) is sized and shaped to mate with the tab of the extending arm 66 d.
- the handgrip portion 12 has a finger trigger 84 and an actuating arm 86 attached thereto, such that when the finger trigger 84 is depressed, the actuating arm 86 slides the mating element 80 in a direction toward the cap 70 (see FIG. 2). As the actuating arm 86 slides the mating element 80 toward the cap 70 , the extending arms 66 a - d of the distal portion 62 (see FIG. 5) of the deployable cage assembly 60 move so as to place the deployable cage assembly 60 into its deployed configuration as shown in FIG. 6. A lock 88 is provided to maintain the deployable cage assembly 60 into its deployed configuration.
- a spring 90 urges the mating element 80 in a direction away from the cap 70 (see FIG. 2). As the spring 90 urges the mating element 80 away from the cap 70 , the extending arms 66 a - d of the distal portion 62 (see FIG. 5) of the deployable cage assembly 60 move so as to place the deployable cage assembly 60 into its relaxed configuration as shown in FIG. 2.
- the extending arms 66 a - d are made from a material, such as spring steel, stainless steel, etc. More particularly, the deployable cage assembly 60 has a length in a range of from about 30 mm to about 80 mm and a diameter in a range from about 3 mm to about 10 mm, when undeployed, and a diameter of about 20 mm to 40 mm when deployed. It will be understood that the above dimensions for the deployable cage assembly 60 are merely exemplary and that the deployable cage assembly 60 can have other dimensions.
- the medical device 10 further includes an impeller cable assembly 92 having an outer tube 94 and an inner tube 96 retained within the outer tube 94 .
- the impeller cable assembly 92 includes a rotary impeller 98 for circulating fluid for reasons described hereinafter and a rotary drive cable 100 for driving the rotary impeller 98 .
- the rotary drive cable 100 has a distal end 102 which is secured within the core 52 of the heating assembly 46 and a proximal end 104 which is connected to the impeller cable 22 (see FIG. 1).
- the rotary impeller 98 includes a plurality of blades 106 attached to the rotary drive cable 100 .
- the blades 106 can be made from a metal or non-metal material.
- the impeller cable assembly 92 and the heater core 52 of the heating assembly 46 form a pump assembly.
- the female uterus 108 includes an external cervical opening 110 ; a cervix 112 having a cervical canal 114 ; an uterus 116 having an uterine cavity 118 ; tubal ostia 120 , 122 ; and Fallopian tubes 124 , 126 .
- the uterine cavity 118 is joined to the Fallopian tubes 124 , 126 via their respective tubal ostia 120 , 122 .
- the uterine cavity 118 includes a plurality of cavity walls in the form of a top wall (hereinafter referred to as a fundus 128 ) and side walls 130 .
- the uterine sound (depth) is measured prior to inserting the thermal ablation catheter 14 . More particularly, a sound (not shown) is inserted into the vaginal orifice (not shown) and guided through the cervical canal 114 , and into the uterine cavity 118 until the sound is in contact with the fundus 128 . The thermal ablation catheter 14 is then inserted into the vaginal orifice (not shown) until a distal portion of the thermal ablation catheter 14 enters the cervix 112 . Note that in the foregoing step, the deployable cage assembly 60 is in its fully relaxed configuration and the distensible bladder 26 is in its fully collapsed configuration.
- the thermal ablation catheter 14 is then guided through the cervical canal 114 , and into the uterine cavity 118 such that the cap 70 is in contact with the fundus 128 of the uterine cavity 118 .
- the distal portion 62 of the deployable cage assembly 60 and the heating assembly 46 are positioned within the uterine cavity 118
- the distensible bladder 26 is positioned within the cervical canal 114 .
- the distensible bladder 26 is then fully inflated with air, via the exterior line 28 (see FIG. 1) so as to assume its fully expanded configuration.
- the distensible bladder 26 When inflated, the distensible bladder 26 is in direct contact with the cervical canal 114 so as to serve as an endocervical seal and so as to thermally insulate the cervix 112 and the vaginal orifice (not shown).
- the deployable cage assembly 60 is deployed, in the manner described previously, into its fully deployed configuration. When deployed, the cage assembly 60 serves to widen the uterine cavity 118 and to center the thermal ablation catheter 14 in place within the uterine cavity 118 . Because the uterine cavity 118 has been widened, the deployable cage assembly 60 also serves to prevent direct contact between the heating assembly 46 and the tissues within the uterine cavity 118 .
- fluid is supplied, via the fluid stem 34 and the fluid outlet ports 56 , to the uterine cavity 118 at a predetermined pressure, until the uterine cavity 118 is filled with fluid.
- fluid can be injected into the uterine cavity 118 prior to deploying the cage assembly 60 .
- the rotary drive cable 100 see FIG. 5 is rotated so as to rotate the rotary impeller 98 (see FIG. 5), which causes the blades 106 (see FIG. 5) to agitate the fluid inside the uterine cavity 118 .
- the fluid is then conductively heated by the heating assembly 46 to a desired temperature, which is maintained for a predetermined time interval. It will be understood that the rotation of the blades 106 continues throughout the heating process.
- the rotary impeller 98 serves to provide uniform heating of the fluid by agitating the fluid surrounding the heating assembly 46 . Because the fluid outlet ports 56 are positioned proximal to the fundus 128 , the heated fluid initially dispenses against the fundus 128 and flows toward the cervical canal 114 . Fluid is circulated within the uterine cavity 118 by flowing into the fluid inlet ports 58 and out of the fluid outlet ports 56 , and the heated fluid thermally ablates the endometrial lining of the uterus 116 .
- the power to the heating assembly 46 is terminated and the fluid is allowed to cool.
- the blades 106 continue to rotate until the fluid has reached a temperature at which it can be safely removed from the uterine cavity 118 .
- the cage assembly 60 is undeployed into its relaxed configuration.
- the cooled fluid is removed, via all fluid ports 56 , 58 and the fluid passageway (not shown), from the uterine cavity 118 .
- the distensible bladder 26 is deflated to its collapsed configuration.
- the thermal ablation catheter 14 is removed from the uterine cavity 118 , the cervical canal 114 , and the vaginal orifice (not shown).
- the present invention provides numerous advantages. For instance, the present invention enables the use of thermal ablation therapy for treating menorrhagia in women who have benign uterine pathology without employing a balloon in the uterine cavity 118 . Because the distensible bladder 26 serves as an endocervical seal, the fluid is prevented from exiting the cervical canal 114 and the vaginal orifice. In such circumstances, only a small amount of fluid is required and the rotary impeller 98 can be small in size. Further, since the heating assembly 46 is used internally within the uterine cavity 118 and a small amount of fluid is required, a small amount of thermal energy is required. In addition, the thermocouples 61 actively monitor and control the temperature inside the uterine cavity 118 .
- the medical device 10 can have numerous modifications and variations.
- the thermal ablation catheter 14 can be either non-disposable or disposable.
- the rotary impeller 98 can be any fluid mixing element (e.g., pump) that serves to circulate fluid. Fluid (e.g., water or a saline solution) rather than air can be used to inflate the distensible bladder 26 to its fully expanded configuration.
- Fluid e.g., water or a saline solution
- Various components of the thermal ablation catheter 14 can be integrally formed from a single tube.
- the outer tube 94 and the inner tube 96 of the impeller cage assembly 92 can be formed from a single tube.
- various configurations of the fluid ports 56 , 58 can provide fluid inlet and fluid outlet from any or all of the fluid ports 56 , 58 .
- the medical device 10 may also employ separate passageways for receiving air and vacuum, rather than a single passageway.
- the ablation catheter 14 may employ alternative energy sources such as RF (radio frequency), laser, ultrasound, chemical, and/or a cryogenic device. All such variations and modifications are intended to be included within the scope of the invention as defined in the appended claims.
Abstract
A medical device is provided and includes a thermal ablation catheter and a deployable cage assembly for use in thermal ablation therapy. The deployable cage assembly includes a plurality of arms, each of which has a pair of opposed ends attached to the thermal ablation catheter. Each of the arms is movable from a relaxed configuration to a deployed configuration. When relaxed, the arms are substantially proximate to the thermal ablation catheter. When deployed, the arms cooperate with each other to form an open structure which extends radially outward from the thermal ablation catheter. The thermal ablation device also includes a distensible bladder that serves as an endocervical seal.
Description
- The present invention relates to a medical device and to a method for thermal ablation, and more specifically to a thermal ablation catheter, having a deployable cage suitable for use in a uterus, for ablation of endometrial cells and tissue within the uterus. As used herein, the term “medical device” includes a medical or surgical device.
- Millions of women suffer from excessive menstrual bleeding (menorrhagia). A commonly used therapy to treat menorrhagia involves inserting a balloon catheter or a distensible bladder into the uterus, filling the balloon with a thermally conductive fluid, and then heating the fluid to thermally ablate the endometrial lining of the uterus. Although thermal balloon therapy is effective for treating menorrhagia in women who have a smooth uterine lining, such balloon therapy is not recommended for women who have uterine conditions such as myomas, polyps, or irregular uterine shapes, etc.
- Accordingly, there is a need for a therapy that involves the use of thermal ablation for treating menorrhagia in women who have benign uterine pathology.
- In accordance with the present invention, there is provided a medical device for use in thermal ablation therapy. The medical device includes a thermal ablation catheter and a deployable cage assembly having a plurality of arms. Each of the arms includes a pair of opposed ends attached to the thermal ablation catheter. Further, each of the arms is movable between a relaxed configuration and a deployed configuration. More particularly, in its relaxed configuration, each of the arms is substantially proximate to the thermal ablation catheter, while in its deployed configuration, it cooperates with the other arms to form an open structure which extends radially outward from the thermal ablation catheter.
- In one embodiment, the thermal ablation catheter includes a fluid stem and a plurality of fluid ports in communication with the fluid stem. The fluid ports are surrounded by the open structure.
- In accordance with another embodiment, the thermal ablation catheter includes a distensible bladder that serves as an endocervical seal. The distensible bladder is sized and shaped to be inflatable from a collapsed configuration to an expanded configuration.
- A method is also disclosed for performing thermal ablation therapy using the medical device. Initially, the distal end of the thermal ablation catheter is inserted into a uterus. The cage assembly is deployed such that it forms an open structure which extends radially outward from the thermal ablation catheter. Then, a fluid is supplied to the uterus through the distal end of the thermal ablation catheter. Lastly, the fluid is conductively heated to a desired temperature which is maintained for a desired time period.
- Other features and aspects of the present invention will become more fully apparent from the following detailed description of the exemplary embodiment, the appended claims and the accompanying drawings.
- For a more complete understanding of the present invention, reference is made to the following detailed description of the exemplary embodiment considered in conjunction with the accompanying drawings, in which:
- FIG. 1 is a front perspective view of a medical device constructed in accordance with the present invention;
- FIG. 2 is a front view of a thermal ablation catheter of the medical device shown in FIG. 1, which shows a deployable cage assembly in a relaxed configuration and a distensible bladder in a collapsed configuration;
- FIG. 3 is a cross-sectional view of the thermal ablation catheter shown in FIG. 2, taken along section lines III-III and looking in the direction of the arrows, illustrated without the distensible bladder;
- FIG. 4 is an enlarged view of the view shown in FIG. 3;
- FIG. 5 is an exploded, perspective view of the thermal ablation catheter shown in FIG. 2, illustrated without the distensible bladder;
- FIG. 6 is a perspective view of the thermal ablation catheter shown in FIG. 2, which shows the deployable cage assembly in a deployed configuration and the distensible bladder in an expanded configuration;
- FIG. 7 is a perspective view of a heating assembly;
- FIG. 8 is a front view of the heating assembly shown in FIG. 7;
- FIG. 9 is a top perspective view of a cap;
- FIG. 10 is a bottom perspective view of the cap shown in FIG. 9;
- FIG. 11 is a cross-sectional view of the cap shown in FIG. 10, taken along section lines XI-XI and looking in the direction of the arrows;
- FIG. 12 is a partial, cross-sectional view of a handgrip portion shown in FIG. 1;
- FIG. 13 is a schematic view of a female uterus and the thermal ablation catheter shown in FIG. 2, which shows a distal portion of the thermal ablation catheter in contact with the uterine cavity; and
- FIG. 14 is a view similar to the view shown in FIG. 13, except that the deployable cage assembly is in a deployed configuration and the distensible bladder is in an expanded configuration.
- FIG. 1 shows a
medical device 10 having ahandgrip portion 12 and athermal ablation catheter 14 removably connected thereto. Various cables are provided for connecting themedical device 10 to external sources. For example, afluid line 16 is provided for connecting themedical device 10 to a fluid source (not shown). Further, acable 18 is provided for connecting themedical device 10 to a controller (not shown). Apressure cable 20 is provided for monitoring pressure throughout the procedure. In addition, animpeller cable 22 is also provided for reasons discussed hereinafter. - With reference to FIG. 2, the
thermal ablation catheter 14 includes an outer sheath ortubular member 24 and adistensible bladder 26 attached thereto. For reasons to be discussed hereinafter, thedistensible bladder 26 is sized and shaped to inflate into a fully expanded configuration as shown in FIG. 6 and to deflate into a fully collapsed configuration as shown in FIG. 2. Referring to FIG. 1, a passageway (not shown) is provided for receiving air and vacuum and is connected to anexterior line 28. - With reference to FIG. 2, the passageway is connected to a perforation in the form of a
vent 29, which is formed on thetubular member 24, located underneath thedistensible bladder 26. The air supplied via the passageway can be used to inflate thedistensible bladder 26 to its fully expanded configuration as shown in FIG. 6, and the vacuum supplied via the passageway can be used to deflate thedistensible bladder 26 to its fully collapsed configuration as shown in FIG. 2. - As illustrated in FIG. 2, the
tubular member 24 includes aproximal end 30 which is sized and shaped to be insertable into the handgrip portion 12 (see FIG. 1) and adistal end 32 which is sized and shaped to be insertable into the uterus for reasons discussed hereinafter. Thetubular member 24 is made from a material, such as stainless steel, teflon, or silicone, which can have a range of stiffness from rigid to flexible. Thetubular member 24 has a length of approximately 230 mm and a diameter in a range from about 3 mm to about 10 mm. It will be understood that the above dimensions for thetubular member 24 are merely exemplary and that thetubular member 24 can have other dimensions. Thedistensible bladder 26 is made from a material, such as latex, silicone, or other elastomeric material, and when inflated, conforms to the shape of the cervical canal so as to seal the cervical canal, as will be discussed in greater detail hereinafter. - Referring to FIG. 5, the
thermal ablation catheter 14 further includes afluid stem 34 sized and shaped to be coaxially received within thetubular member 24. Thefluid stem 34 includes aproximal end 36 and adistal end 38. A passageway (not shown) is provided for receiving a fluid (e.g., water, saline solution, high viscous gelatins, glycerol, propylene glycol, etc.). Although any of the fluids can be used, the preferred fluids are the high viscous gelatins due to their controllability. The passageway extends between theproximal end 36 and thedistal end 38 and is connected to the fluid line 16 (see FIG. 1). - Still referring to FIG. 5, the
fluid stem 34 has four longitudinal grooves on its outer surface so as to form four longitudinally extending bars 42 a-d. Alongitudinal groove 44 a is formed between an adjacent pair of bars 42 a-b, while a longitudinal groove 44 b is formed between an adjacent pair of bars 42 b-c. Also, alongitudinal groove 44 c is formed between an adjacent pair of bars 42 c-d, while alongitudinal groove 44 d is formed between an adjacent pair ofbars 42 d-a. - The fluid stem34 is made from a material, such as stainless steel, Teflon, nitinol, etc. As illustrated in FIG. 5, the
fluid stem 34 has a diameter that is smaller than that of thetubular member 24. - With reference to FIG. 5, a
heating assembly 46 is provided and is sized and shaped to be coaxially received within thefluid stem 34. More particularly, theheating assembly 46 has aheater core 52 which extends from thetubular member 24, when assembled as shown in FIG. 2, and anextension 50 which is sized and shaped to be coaxially received within thedistal end 38 of thefluid stem 34. Referring to FIGS. 7 and 8, theheating assembly 46 includes a heater filament orwire 54 wrapped around theheater core 52. Heater wire leads (not shown) extend between the cable 18 (see FIG. 1) and theheating wire 54. A plurality offluid outlet ports 56 is circumferentially positioned adjacent adistal end 57 of theheating assembly 46, while a plurality offluid inlet ports 58 is circumferentially positioned adjacent aproximal end 59 of theheating assembly 46. Thefluid outlet ports 56 and thefluid inlet ports 58 are in communication with the passageway of the fluid stem 34 (see FIG. 5). Thermocouples 61 can be employed within theheating assembly 46 to provide monitoring and control of the temperature within theuterine cavity 118. - FIG. 5 illustrates a
deployable cage assembly 60 which cooperates with thefluid stem 34 and is coaxially received over theheating assembly 46. Thedeployable cage assembly 60 is sized and shaped to move between a deployed configuration as shown in FIG. 6, and a relaxed configuration as shown in FIG. 2. Referring to FIG. 5, thedeployable cage assembly 60 has adistal portion 62 which is coaxially received over theheating assembly 46 and aproximal portion 64 which cooperates with thefluid stem 34. - Still referring to FIG. 5, the
deployable cage assembly 60 includes four longitudinally extending arms 66 a-d, each of which is movable from a relaxed configuration (see FIG. 2), in which the extending arms 66 a-d are proximate to thethermal ablation catheter 14 and have an unbowed shape, to a deployed configuration (see FIG. 6), in which the extending arms 66 a-d have a bowed shape and cooperate with each other to form an arcuate-shaped open structure 63 (see FIG. 6), which extends radially outward from thethermal ablation catheter 14. Theopen structure 63 is located on thedistal portion 62 of thedeployable cage assembly 60 and is exposed (i.e., not covered by the tubular member 24). More particularly, the extendingarm 66 a is sized and shaped to be received within thelongitudinal groove 44 a formed between the bars 42 a-b of thefluid stem 34, while the extending arm 66 b is sized and shaped to be received within the longitudinal groove 44 b formed between the bars 42 b-c of thefluid stem 34. Also, the extendingarm 66 c is sized and shaped to be received within thelongitudinal groove 44 c formed between the bars 42 c-d, while the extending arm 66 d is sized and shaped to be received within thelongitudinal groove 44 d formed between thebars 42 d-a. The extendingarm 66 a has a fixed end 68 a at thedistal portion 62 and a tab 69 a at a free end and at theproximal portion 64 extending perpendicularly to the extendingarm 66 a, while the extending arm 66 b has a fixed end 68 b at thedistal portion 62 and a tab 69 b at a free end and at theproximal portion 64 extending perpendicularly to the extending arm 66 b. Further, the extendingarm 66 c has a fixed end 68 c at thedistal portion 62 and a tab 69 c at a free end and at theproximal portion 64 extending perpendicularly to the extendingarm 66 c, while the extending arm 66 d has a fixed end (not shown) at thedistal portion 62 and a tab (not shown) at a free end and at theproximal portion 64 extending perpendicularly to the extending arm 66 d. - With reference to FIG. 5, a
cap 70 is connected to the extending arms 66 a-d at thedistal portion 62 of thedeployable cage assembly 60 and is coaxially received over thedistal end 57 of the heating assembly 46 (see FIG. 7). Referring to FIGS. 9-11, thecap 70 includes acylindrical portion 72 and a connectingelement 74 attached thereto. The connectingelement 74 includes acenter portion 75 defined by alumen 76 sized and shaped to coaxially receive thedistal end 57 of the heating assembly 46 (see FIG. 7), and also includes four projections 78 a-d extending from thecenter portion 75. Anopening 80 a is formed between an adjacent pair of projections 78 a-b and is sized and shaped to receive the end 68 a of the extendingarm 66 a (see FIG. 5), while an opening 80 b is formed between an adjacent pair ofprojections 78 b-c and is sized and shaped to receive the end 68 b of the extending arm 66 b (see FIG. 5). Also, anopening 80 c is formed between an adjacent pair of projections 78 c-d and is sized and shaped to receive the end 68 c of the extendingarm 66 c (see FIG. 5), while anopening 80 d is formed between an adjacent pair ofprojections 78 d-a and is sized and shaped to receive the end of the extending arm 66 d (see FIG. 5). - With reference to FIG. 5, the
deployable cage assembly 60 also includes amating element 80 located at theproximal portion 64 and sized and shaped to be received within the handgrip portion 12 (see FIG. 1). As will be discussed in greater detail hereinafter, themating element 80 is movable between a retracted position, in which the tabs 69 a-c of the extending arms 66 a-d are spaced a first distance from the fix ends 68 a-c thereof, and an extended position, in which the tabs 69 a-c are spaced a second distance from the fixed ends 68 a-c, the second distance being less than the first distance. Themating element 80 has a plurality of circumferentially spaced slots. More particularly, a slot 82 a is sized and shaped to mate with the tab 68 a of the extendingarm 66 a, while a slot 82 b is sized and shaped to mate with the tab 68 b of the extending arm 66 b. Also, a slot (not shown) is sized and shaped to mate with the tab 68 c of the extendingarm 66 c, while a slot (not shown) is sized and shaped to mate with the tab of the extending arm 66 d. - As illustrated in FIG. 12, the
handgrip portion 12 has afinger trigger 84 and anactuating arm 86 attached thereto, such that when thefinger trigger 84 is depressed, theactuating arm 86 slides themating element 80 in a direction toward the cap 70 (see FIG. 2). As theactuating arm 86 slides themating element 80 toward thecap 70, the extending arms 66 a-d of the distal portion 62 (see FIG. 5) of thedeployable cage assembly 60 move so as to place thedeployable cage assembly 60 into its deployed configuration as shown in FIG. 6. Alock 88 is provided to maintain thedeployable cage assembly 60 into its deployed configuration. When thelock 88 and thefinger trigger 84 are released, aspring 90 urges themating element 80 in a direction away from the cap 70 (see FIG. 2). As thespring 90 urges themating element 80 away from thecap 70, the extending arms 66 a-d of the distal portion 62 (see FIG. 5) of thedeployable cage assembly 60 move so as to place thedeployable cage assembly 60 into its relaxed configuration as shown in FIG. 2. - The extending arms66 a-d are made from a material, such as spring steel, stainless steel, etc. More particularly, the
deployable cage assembly 60 has a length in a range of from about 30 mm to about 80 mm and a diameter in a range from about 3 mm to about 10 mm, when undeployed, and a diameter of about 20 mm to 40 mm when deployed. It will be understood that the above dimensions for thedeployable cage assembly 60 are merely exemplary and that thedeployable cage assembly 60 can have other dimensions. - Referring to FIG. 5, the
medical device 10 further includes animpeller cable assembly 92 having anouter tube 94 and an inner tube 96 retained within theouter tube 94. Theimpeller cable assembly 92 includes arotary impeller 98 for circulating fluid for reasons described hereinafter and arotary drive cable 100 for driving therotary impeller 98. More particularly, therotary drive cable 100 has adistal end 102 which is secured within thecore 52 of theheating assembly 46 and a proximal end 104 which is connected to the impeller cable 22 (see FIG. 1). As illustrated in FIG. 5, therotary impeller 98 includes a plurality ofblades 106 attached to therotary drive cable 100. Theblades 106 can be made from a metal or non-metal material. Theimpeller cable assembly 92 and theheater core 52 of theheating assembly 46 form a pump assembly. - In order to fully understand the advantages of the
medical device 10, a brief overview of thefemale uterus 108 is discussed below with reference to FIGS. 13-14. Thefemale uterus 108 includes an externalcervical opening 110; acervix 112 having acervical canal 114; anuterus 116 having anuterine cavity 118;tubal ostia Fallopian tubes uterine cavity 118 is joined to theFallopian tubes tubal ostia uterine cavity 118 includes a plurality of cavity walls in the form of a top wall (hereinafter referred to as a fundus 128) andside walls 130. - In operation, prior to inserting the
thermal ablation catheter 14, the uterine sound (depth) is measured. More particularly, a sound (not shown) is inserted into the vaginal orifice (not shown) and guided through thecervical canal 114, and into theuterine cavity 118 until the sound is in contact with thefundus 128. Thethermal ablation catheter 14 is then inserted into the vaginal orifice (not shown) until a distal portion of thethermal ablation catheter 14 enters thecervix 112. Note that in the foregoing step, thedeployable cage assembly 60 is in its fully relaxed configuration and thedistensible bladder 26 is in its fully collapsed configuration. - As illustrated in FIG. 13, the
thermal ablation catheter 14 is then guided through thecervical canal 114, and into theuterine cavity 118 such that thecap 70 is in contact with thefundus 128 of theuterine cavity 118. In this position, thedistal portion 62 of thedeployable cage assembly 60 and theheating assembly 46 are positioned within theuterine cavity 118, while thedistensible bladder 26 is positioned within thecervical canal 114. Turning now to FIG. 14, thedistensible bladder 26 is then fully inflated with air, via the exterior line 28 (see FIG. 1) so as to assume its fully expanded configuration. When inflated, thedistensible bladder 26 is in direct contact with thecervical canal 114 so as to serve as an endocervical seal and so as to thermally insulate thecervix 112 and the vaginal orifice (not shown). Next, thedeployable cage assembly 60 is deployed, in the manner described previously, into its fully deployed configuration. When deployed, thecage assembly 60 serves to widen theuterine cavity 118 and to center thethermal ablation catheter 14 in place within theuterine cavity 118. Because theuterine cavity 118 has been widened, thedeployable cage assembly 60 also serves to prevent direct contact between theheating assembly 46 and the tissues within theuterine cavity 118. - After the
deployable cage assembly 60 in its fully deployed configuration and thedistensible bladder 26 in its fully expanded configuration, fluid is supplied, via thefluid stem 34 and thefluid outlet ports 56, to theuterine cavity 118 at a predetermined pressure, until theuterine cavity 118 is filled with fluid. Alternatively, fluid can be injected into theuterine cavity 118 prior to deploying thecage assembly 60. When the fluid has filled theuterine cavity 118, the rotary drive cable 100 (see FIG. 5) is rotated so as to rotate the rotary impeller 98 (see FIG. 5), which causes the blades 106 (see FIG. 5) to agitate the fluid inside theuterine cavity 118. As theblades 106 rotate, the fluid is then conductively heated by theheating assembly 46 to a desired temperature, which is maintained for a predetermined time interval. It will be understood that the rotation of theblades 106 continues throughout the heating process. Therotary impeller 98 serves to provide uniform heating of the fluid by agitating the fluid surrounding theheating assembly 46. Because thefluid outlet ports 56 are positioned proximal to thefundus 128, the heated fluid initially dispenses against thefundus 128 and flows toward thecervical canal 114. Fluid is circulated within theuterine cavity 118 by flowing into thefluid inlet ports 58 and out of thefluid outlet ports 56, and the heated fluid thermally ablates the endometrial lining of theuterus 116. After a predetermined time interval, the power to theheating assembly 46 is terminated and the fluid is allowed to cool. Theblades 106 continue to rotate until the fluid has reached a temperature at which it can be safely removed from theuterine cavity 118. Then, thecage assembly 60 is undeployed into its relaxed configuration. Next, the cooled fluid is removed, via allfluid ports uterine cavity 118. - Thereafter, the
distensible bladder 26 is deflated to its collapsed configuration. Lastly, thethermal ablation catheter 14 is removed from theuterine cavity 118, thecervical canal 114, and the vaginal orifice (not shown). - It should be appreciated that the present invention provides numerous advantages. For instance, the present invention enables the use of thermal ablation therapy for treating menorrhagia in women who have benign uterine pathology without employing a balloon in the
uterine cavity 118. Because thedistensible bladder 26 serves as an endocervical seal, the fluid is prevented from exiting thecervical canal 114 and the vaginal orifice. In such circumstances, only a small amount of fluid is required and therotary impeller 98 can be small in size. Further, since theheating assembly 46 is used internally within theuterine cavity 118 and a small amount of fluid is required, a small amount of thermal energy is required. In addition, the thermocouples 61 actively monitor and control the temperature inside theuterine cavity 118. - It should be noted that the
medical device 10 can have numerous modifications and variations. For instance, thethermal ablation catheter 14 can be either non-disposable or disposable. Therotary impeller 98 can be any fluid mixing element (e.g., pump) that serves to circulate fluid. Fluid (e.g., water or a saline solution) rather than air can be used to inflate thedistensible bladder 26 to its fully expanded configuration. Various components of thethermal ablation catheter 14 can be integrally formed from a single tube. For instance, theouter tube 94 and the inner tube 96 of theimpeller cage assembly 92 can be formed from a single tube. Also, various configurations of thefluid ports fluid ports medical device 10 may also employ separate passageways for receiving air and vacuum, rather than a single passageway. Further, theablation catheter 14 may employ alternative energy sources such as RF (radio frequency), laser, ultrasound, chemical, and/or a cryogenic device. All such variations and modifications are intended to be included within the scope of the invention as defined in the appended claims.
Claims (21)
1. A medical device for use in thermal ablation therapy, comprising a thermal ablation catheter; and a deployable cage assembly having a plurality of arms, each of which includes a pair of opposed ends attached to said thermal ablation catheter, each of said arms being movable from a relaxed configuration, in which it is substantially proximate to said thermal ablation catheter, to a deployed configuration, in which it cooperates with the other of said arms to form an open structure which extends outward from said thermal ablation catheter.
2. A medical device in accordance with claim 1 , wherein one of said opposed ends is a fixed end and the other of said opposed ends is a free end.
3. A medical device in accordance with claim 2 , further comprising a slidable element movable between a retracted position, in which said free ends are spaced a first distance from said fix ends, and an extended position, in which said free ends are spaced a second distance from said fixed ends, said second distance being less than said first distance.
4. A medical device in accordance with claim 3 , wherein said thermal ablation catheter includes a distal end and a cap attached to said distal end and to said fix ends of said arms.
5. A medical device in accordance with claim 4 , wherein said slidable element moves to its said extended position when said slidable element moves toward said cap, and said slidable element moves to its said retracted position when said slidable element moves away from said cap.
6. A medical device in accordance with claim 5 , wherein each of said arms has an unbowed shape when each of said arms is in its said relaxed configuration, and wherein each of said arms has a bowed shape when each of said arms is in its said deployed configuration, thereby imparting an arcuate shape to said open structure.
7. A medical device in accordance with claim 1 , wherein said thermal ablation catheter further includes an outer sheath covering a portion of said deployable cage assembly.
8. A medical device in accordance with claim 7 , wherein said open structure is exposed so as to be located outside of said outer sheath.
9. A medical device in accordance with claim 8 , further comprising a distensible bladder being inflatable from a collapsed configuration to an expanded configuration, said distensible bladder being attached to said outer sheath.
10. A medical device in accordance with claim 9 , wherein said thermal ablation catheter further includes a fluid stem positioned within said outer sheath so as to allow a fluid to pass through said thermal ablation catheter.
11. A medical device in accordance with claim 10 , wherein said fluid stem includes a plurality of grooves, each of said grooves sized and shaped to receive one of said arms of said deployable cage assembly.
12. A medical device in accordance with claim 11 , wherein said thermal ablation catheter further includes a heater assembly received within said fluid stem.
13. A medical device in accordance with claim 12 , wherein said heating assembly includes thermocouples.
14. A medical device in accordance with claim 13 , wherein said heating assembly further includes a plurality of fluid outlet ports and a plurality of fluid inlet ports, said fluid outlet ports and said fluid inlet ports being in communication with said fluid stem.
15. A medical device in accordance with claim 14 , wherein said thermal ablation catheter further includes an impeller having a plurality of blades sized and shaped to circulate a fluid.
16. A medical device for use in thermal ablation therapy, comprising a thermal ablation catheter having a fluid stem and a plurality of fluid ports in communication with said fluid stem; and a deployable cage assembly having a plurality of arms, each of said arms being movable from a relaxed configuration, in which it is substantially proximate to said thermal ablation catheter, to a deployed configuration, in which it cooperates with the other of said arms to form an open structure which extends outward from said thermal ablation catheter, said open structure surrounding said fluid ports.
17. A medical device in accordance with claim 16 , wherein said fluid ports include a plurality of fluid outlet ports and a plurality of fluid inlet ports, said fluid outlet ports and said fluid inlet ports being in communication with said fluid stem.
18. A medical device in accordance with claim 17 , wherein said thermal ablation catheter further includes a heating assembly located between said fluid outlet Ports and said fluid inlet ports.
19. A medical device in accordance with claim 18 , wherein said thermal ablation catheter further includes an impeller sized and shaped to circulate a fluid.
20. A method for performing thermal ablation therapy using a medical device which includes a thermal ablation catheter and a deployable cage assembly attached to a distal end of said thermal ablation catheter, said method comprising the steps of:
(a) inserting said distal end of said thermal ablation catheter into a cavity;
(b) deploying said cage assembly such that said cage assembly forms an open structure which extends outward from said thermal ablation catheter;
(c) supplying a fluid to the cavity through said thermal ablation catheter; and
(d) conductively heating the fluid within the cavity to a desired temperature and maintaining the temperature for a desired time period.
21. The method of claim 20 , further comprising the steps of:
(e) providing a distensible bladder; and
(f) inflating said distensible bladder when said distensible bladder is positioned within the cervical canal and prior to the performance of step (d).
Priority Applications (3)
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AU2003280048A AU2003280048A1 (en) | 2002-06-26 | 2003-06-18 | Thermal ablation with deployable cage |
PCT/US2003/019356 WO2004002347A1 (en) | 2002-06-26 | 2003-06-18 | Thermal ablation with deployable cage |
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US10/183,600 US6960203B2 (en) | 2002-06-26 | 2002-06-26 | Thermal ablation with deployable cage |
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WO2004002347A1 (en) | 2004-01-08 |
US6960203B2 (en) | 2005-11-01 |
AU2003280048A1 (en) | 2004-01-19 |
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